How can the reform of the activity-based payment system (T2A) help in financing innovative health products?

In France, the short-stay activities of public and private sector healthcare facilities have been financed since 2004 by activity-based pricing (T2A). The principle is to allow for payment determined primarily by the nature and volume of activities. T2A has enabled a major transformation compared to the old financing system, chiefly for public sector facilities that used to operate under a general allocation, and convergence between payment methods in the public and private sectors.

Reflector-guided localization compared with wire-guided localization for non-palpable breast cancer resection: organizational impacts and costs analysis.

Background: Wire-guided localization (WGL) for non-palpable breast cancer lesions has drawbacks like wire migration, localization difficulties, and logistical challenges. Wireless methods, such as reflector-guided localization (RGL), address these issues and are compatible with breast MRI. This study evaluates the organizational and cost impacts of RGL compared to WGL.

Early access programs for medical devices in France: Overview of recent reforms and outcomes (2015-2022).

The medical technology sector is characterised by a constant influx of innovations with the potential to revolutionise patient care. In France, there are several pathways for medical devices to enter the market, from diagnosis-related group tariffs to reimbursement lists. However, traditional regulatory pathways can delay market access for innovative technologies.

Overcoming Barriers in Hospital-Based Health Technology Assessment (HB-HTA): International Expert Panel Consensus.

The purpose of this article is to investigate the common facilitators and barriers associated with the implementation of hospital-based health technology assessment (HB-HTA) across diverse hospital settings in seven countries. Through a two-round Delphi study, insights were gathered from a panel of 15 HTA specialists from France, Hungary, Italy, Kazakhstan, Poland, Switzerland, and Ukraine. Experts initially conducted a comprehensive review of the HB-HTA implementation in their respective countries, identifying the barriers and facilitators through descriptive analysis.

Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs.

Background: An ambitious reform of the early access (EA) process was set up in July 2021 in France, aiming to simplify procedures and accelerate access to innovative drugs.

Objective: This study analyzes the characteristics of oncology drug approvals through the EA process and its impact on real-life data for oncology patients.

Methods: The number and characteristics of EA demands concerning oncology drugs submitted to the National Health Authority (HAS, Haute Autorité de Santé) were reviewed until 31 December 2022.

Hospital-based health technology assessment of innovative medical devices: insights from a nationwide survey in France.

Objectives: To better understand the process of hospital acquisition of innovative medical devices (MDs) and the hospital-based health technology assessment (HB-HTA) pathways in France, an in-depth study based on a quantitative approach is needed. The aim of the present study was to assess through a national survey how HB-HTA is currently implemented in French hospitals and to identify its level of formalization.

Methods: A quantitative online survey was conducted among hospitals performing HB-HTA in France, with a focus on the acquisition of innovative MDs for individual use.

Are current clinical studies on artificial intelligence-based medical devices comprehensive enough to support a full health technology assessment? A systematic review.

Introduction: Artificial Intelligence-based Medical Devices (AI-based MDs) are experiencing exponential growth in healthcare. This study aimed to investigate whether current studies assessing AI contain the information required for health technology assessment (HTA) by HTA bodies.

Methods: We conducted a systematic literature review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology to extract articles published between 2016 and 2021 related to the assessment of AI-based MDs.